UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052032 |
|---|---|
| Receipt number | R000059295 |
| Scientific Title | Research for identifying aggravating factors and establishing effective interventions to prevent dementia progression |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2025/02/28 15:02:59 |
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Basic information
Public title
Research for identifying aggravating factors and establishing effective interventions to prevent dementia progression
Acronym
aggravating factors and prevention in dementias
Scientific Title
Research for identifying aggravating factors and establishing effective interventions to prevent dementia progression
Scientific Title:Acronym
aggravating factors and prevention in dementias
Region
| Japan |
Condition
Condition
Dementia (Alzheimer's disease, dementia with Lewy bodies, frontotemporal lobar degeneration, argyrophilic grain disease, limbic predominant age-related TDP-43 encephalopathy)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To identifying aggravating factors of dementia, multiple parameters of dementia including socio-psychological factors, clinical symptoms, brain image findings, genetic risk factors and neuropathological findings are investigated retrospectively and prospectively. Based on these results, we propose the possible intervention preventing dementia progression by a correct understanding of various types of dementia.
Basic objectives2
Others
Basic objectives -Others
Use of care services and their effect on the rate of dementia progression
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MMSE total scores in every 12 months.Presence or absence of a drop of 3 points or more from the baseline.
Key secondary outcomes
Clinical dementia rating, independence rating score in daily life of dementia, Neuropsychiatric inventory (NPI), neuropsychological assessments, hippocampal atrophy on MRI, arterial spin labeling, cerebral blood flow on SPECT, dopamine transporter imagings, amyloid PET, neuropathological findings
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Retrospective study
1.Patients diagnosed with Alzheimer's disease(AD), dementia with Lewy bodies(DLB), frontotemporal lobar degeneration(FTLD), argyrophilic grain disease(AGD), or limbic predominant age-related TDP-43 encephalopathy(LATE) based on the following diagnostic criteria
AD: Diagnostic criteria for AD from the National Institute of Aging and the Alzheimer Association(NIA-AA)
DLB: Clinical diagnostic criteria for DLB by McKeith et al. (2017)
FTLD: Diagnostic criteria for bvFTD by Rascovsky et al. (2011) and SD and PNFA by Gorno-Tempini et al. (2011)
AGD: Guidelines for the Treatment of Dementia Diseases 2017, Japanese Society of Neurology
LATE: Based on the report of Nelson et al. (2022) and imaging findings of hippocampal sclerosis on MRI
2.Patients with head MRI and VSRAD results using Voxel-based morphometry (VBM)
3.Patients who have consented to participate in previous dementia studies and opt out
Prospective study
1.Outpatients or first-time patients diagnosed based on the same criteria as in 1 of the retrospective studies
2.Patients who have consented to participate in this study
Key exclusion criteria
Patients with schizophrenia, alcoholism, and extensive cerebrovascular disease
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Shinobu |
| Middle name | |
| Last name | Kawakatsu |
Organization
Aizu Medical Center, Fukushima Medical University
Division name
Department of Neuropsychiatry
Zip code
969-3492
Address
21-2 Kawahigashimachi Tanisawa, Aizuwakamatsu City, Fukushima, Japan
TEL
0242-75-2100
kshinobu@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Shinobu |
| Middle name | |
| Last name | Kawakatsu |
Organization
Aizu Medical Center, Fukushima Medical University
Division name
Department of Neuropsychiatry
Zip code
969-3492
Address
21-2 Kawahigashimachi Tanisawa, Aizuwakamatsu City, Fukushima, Japan
TEL
0242-75-2100
Homepage URL
kshinobu@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University
Address
1 Hikariga-oka, Fukushima City 960-1295, JAPAN
Tel
024-547-1111
kshinobu@fmu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
福島県立医科大学会津医療センター（福島県）、福島県立医科大学認知症疾患医療センター（福島県）、福島県立南会津病院認知症疾患医療センター（福島県）、竹田綜合病院認知症疾患医療センター、山形大学医学部附属病院（山形県）、篠田総合病院認知症疾患医療センター（山形県）、日本海総合病院認知症疾患医療センター（山形県）、東北大学病院（宮城県）、弘前大学（青森県）、名古屋大学（愛知県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Follow-up assessment every 1 year in principle, every 6 months if possible
Management information
Registered date
| 2023 | Year | 08 | Month | 28 | Day |
Last modified on
| 2025 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059295
